510(k) K062126

EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 by Biosphere Medical, Inc. — Product Code DQO

K062126 is an FDA 510(k) premarket notification submitted by Biosphere Medical, Inc. for the device "EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135". The FDA issued a decision of Substantially Equivalent on August 9, 2006. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Biosphere Medical, Inc. has at least 10 other 510(k) clearances on record.